What the label lists and what reports show
Meclizine side effects
Meclizine's FDA label lists its adverse reactions in its own words. FAERS holds 19,471 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (1,951 reports).
- Generic listed
Check it at the source: the meclizine FDA label on DailyMed (effective June 2, 2025, Rising Pharma Holdings, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported. Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Source: FDA drug label, Rising Pharma Holdings, Inc., effective June 2, 2025 (SPL set c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,471 reports list meclizine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,695 are coded as a death and 5,856 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Meclizine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions